Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 28, 2026 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks, under “Claim Rejections – 35 U.S.C. § 103”, on pages 5-9, filed on 1/28/2026, with respect to the rejection(s) of claim(s) 1-14 and 17-20 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art reference that reject the amendments made when combined with prior arts.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-6, 9-14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cattaneo (US Pub No. 20180256176 A1) in view of Alesi et al. (EP 1481698 A2, herein, Alesi) and Goble et al. (US 20070073268 A1). For ease of discussion, all citations below refer to the translation of Alesi provided in the Foreign Reference document provided on 10/29/2025.
Regarding claim 1, Cattaneo discloses a catheter system comprising:
a major lumen (2 – Fig.4) having a proximal opening (shown at 2 in Fig.2) and a distal opening (5 – Fig.4), the limitation, “the major lumen configured to remove blood from the left ventricle of the heart” is interpreted to be a functional limitation (the major lumen is capable of removing blood from the left ventricle of the heart since it is an aspiration unit for suction (Para [0007], “treatment of stenoses in the heart” – Para [0040]); and
a minor lumen (3 – Fig.4) connected to the major lumen (Fig.4), the minor lumen including an aperture (4 – Fig.4) positioned on a radial surface of an outer wall of the minor lumen (Fig.4) and positioned to prevent fluid communication with the major lumen, the aperture located at a distal region of the major lumen (Fig.4),
and the limitation, “wherein the minor lumen is configured to deliver a treatment substance directly into the left ventricle during simultaneous removal of blood from the left ventricle through the major lumen” is interpreted to be a functional limitation (the minor lumen is capable of delivering a treatment substance directly into the left ventricle since the system comprises all the elements provided above, “simultaneous treatment of a patient during an aspiration is also possible” – Para [0031], “The aspiration system allows simultaneous aspiration of the thrombus and cooling of the vessel” – Para [0050]).
However, Cattaneo does not expressly disclose wherein the minor lumen extends separately from the major lumen over a length of the major lumen and wherein the catheter system is sized to traverse through a percutaneous incision in a patient through an aorta of the heart and into the left ventricle of the heart and wherein the minor lumen is configured to measure left heart pressure.
Goble teaches a minor lumen (10 – Fig.1) extending separately from the major lumen (15 – Fig.1) over a length of the major lumen (Fig.1).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the lumens disclosed by Cattaneo to have the minor lumen extend separately from the major lumen as taught by Goble since Goble teaches that the portion of the minor lumen extending separately is to connect the lumen to the treatment substance to infuse into the patient.
Alesi teaches a catheter system wherein the catheter system is sized to traverse through a percutaneous incision in a patient through an aorta of the heart and into the left ventricle of the heart (“inflow cannula is percutaneously inserted through subclavian artery to the aorta "A" and advanced through the aortic valve "AV" with the inflow ports of the tube positioned within the left ventricle” – Para [0068]) and wherein the minor lumen is configured to measure left heart pressure (94 – Fig.1, “Pressure transducer is utilized to detect pressure within the heart chamber.” – Para [0025]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the catheter system disclosed by Cattaneo to be sized to traverse through percutaneous incision in a patient through an aorta of the heart and into the left ventricle of the heart and wherein the minor lumen is configured to measure pressure as taught by Alesi to allow for a minimally invasive incision in the patient for quicker recovery, reduced pain, and lower infection risk and Alesi also teaches that a pressure sensor helps the user control the pressure in the heart to prevent patient complications (Alesi, Para [0025]).
Regarding claim 4, Cattaneo discloses the catheter system, as modified above, comprising one or more intake apertures (5 – Fig.4) disposed in the distal region of the major lumen (2 – Fig.4).
Regarding claim 5, Cattaneo discloses the catheter system, as modified above, wherein the aperture (4 – Fig.4) of the minor lumen (3 – Fig.4) is radially offset from the one or more intake apertures (5 – Fig.4) in the major lumen (2 – Fig.4).
Regarding claim 6, Cattaneo discloses the catheter system, as modified above, wherein the major lumen (2 – Fig.4) includes a first axis and wherein the one or more intake apertures includes a second axis oriented perpendicular to the first axis (see annotated Fig. 4 below).
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Regarding claim 9, Cattaneo discloses the catheter system, as modified above, wherein the major lumen (2 – Fig.4) includes a first axis and the minor lumen (3 – Fig.4) includes a second axis, and wherein the first axis and the second axis are parallel along at least a portion of a length of the major lumen and the minor lumen (See annotated Fig.4 below).
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Regarding claim 10, Cattaneo discloses the catheter system, as modified above, wherein the major lumen (2 – Fig.4) includes a first diameter and the minor lumen (3 – Fig.4) includes a second diameter, and wherein the first diameter is greater than the second diameter (Fig.3a, Fig.5).
Regarding claim 11, Cattaneo discloses the catheter system, as modified above, wherein the major lumen (2 – Fig.4) includes a first portion having a first diameter and a second portion having a second diameter, and wherein the second diameter is greater than the first diameter (“the aspiration lumen may be larger at the distal end” – Para [0059]).
Regarding claim 12, Cattaneo discloses the catheter system, as modified above, wherein the major lumen (2 – Fig.4) includes a first axis and wherein the proximal opening is co-axial with the first axis (See annotated Fig.4 above).
Regarding claim 13, Cattaneo discloses the catheter system above, as modified, wherein the catheter system includes a major lumen (2 – Fig.4) and a minor lumen (3 – Fig.4) but Cattaneo does not expressly disclose a method comprising:
inserting the catheter system into the heart through a percutaneous incision in the subject through an aorta of the heart and into a left ventricle of the heart;
connecting the major lumen to a peripheral device for oxygenating blood from the left ventricle; and
simultaneously delivering a treatment substance directly into the left ventricle with the minor lumen and withdrawing blood from the left ventricle through the major lumen.
Alesi teaches a method of inserting a catheter system (70 – Fig.20) into the heart through a percutaneous incision in the subject through an aorta of the heart and into a left ventricle of the heart (“inflow cannula 70 is percutaneously inserted through subclavian artery to the aorta "A" and advanced through the aortic valve "AV" with the inflow ports 80 of the tube 14 positioned within the left ventricle” – Para [0068]);
connecting a major lumen (12- Fig.2B) (70– Fig.20) to a peripheral device (12 – Fig.20) for oxygenating blood from the left ventricle (Para [0069],Para [0007], lines 1-6); and
Simultaneously delivering a treatment substance directly into the left ventricle with the minor lumen (14 – Fig.2B)(14 – Fig.20) and withdrawing blood from the left ventricle through the major lumen (“During use, cardioplegia fluid or venting capabilities may be introduced via inflow catheter tube” – Para [0069]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the catheter system disclosed by Cattaneo to be sized to traverse through percutaneous incision in a patient through an aorta of the heart and into the left ventricle of the heart as taught by Alesi to allow for a minimally invasive incision in the patient for quicker recovery, reduced pain, and lower infection risk.
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the method of delivering a treatment substance a subject disclosed by Cattaneo, as modified, to connect the major lumen to a peripheral device and simultaneously delivering a treatment substance directly into the left ventricle with the minor lumen and withdrawing blood from the left ventricle through the major lumen as taught by Alesi since the major lumen allows for more blood to be oxygenated allowing for quicker healing time and supporting immune and cognitive functions while the minor lumen allows for medication to be delivered during the oxygenation for improved drug effectiveness.
Regarding claim 14, Cattaneo discloses the catheter system above, but Cattaneo does not expressly disclose a method further comprising measuring pressure in the heart with the minor lumen.
Alesi teaches a method comprising measuring pressure (94 – Fig.1) in the heart with a minor lumen (14 – Fig.20)(“Pressure transducer is utilized to detect pressure within the heart chamber.” – Para [0025]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the catheter system disclosed by Cattaneo, as modified, to measure pressure as taught by Alesi since Alesi teaches that a pressure sensor helps the user control the pressure in the heart to prevent patient complications (Alesi, Para [0025]).
Regarding claim 19, Cattaneo discloses the catheter system, as modified above, wherein the minor lumen includes a cross-sectional area that is smaller than the cross-sectional area of the major lumen (Fig.4) but fails to explicitly disclose wherein the minor lumen includes a cross-sectional area that is 5-10% of a cross-sectional area of the major lumen.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size/proportion of the minor lumen of Cattaneo to have a 5-10% cross-sectional of the major lumen since it has been held that mere changes in size/proportion are obvious, MPEP 2144.04 IV A: In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In the instant case, the device of Cattaneo would not operate differently with the claimed size/proportion of the minor lumen considering Cattaneo discloses a minor lumen with a cross-sectional area that is smaller than the cross-sectional area of the major lumen. Further, applicant places no criticality on the size/proportion claimed, indicating simply, “the minor lumen 112 is about 5-10% of the cross-sectional area of the major lumen 110” (Para [0035]).
Claims 2 and 18 is rejected under 35 U.S.C. 103 as being unpatentable over Cattaneo in view of Alesi and Goble as applied in claim 1 above, and further in view of Tsubouchi (US Pub No. 20190070352 A1).
Regarding claim 2, Cattaneo discloses the catheter system, as modified above, comprising a treatment substance (Para [0009]) but Cattaneo does not expressly disclose wherein the treatment substance comprises an anticoagulant.
Tsubouchi teaches a treatment substance comprises an anticoagulant (“anticoagulant such as heparin” – Para [0004]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the treatment substance disclosed by Cattaneo, as modified, to comprise an anticoagulant as taught by Tsubouchi since Tsubouchi teaches that during extracorporeal circulation, blood is in an environment likely to be in contact with foreign bodies such as air, activated blood is likely to clot and form a thrombus so a thrombus is inhibited from being formed by giving a dose of an anticoagulant (Tsubouchi, Para [0004]).
Regarding claim 18, Cattaneo discloses the catheter system, as modified above, comprising a treatment substance (Para [0009]) but Cattaneo does not expressly disclose wherein the treatment substance comprises an anticoagulant.
Tsubouchi teaches a treatment substance comprises an anticoagulant (“anticoagulant such as heparin” – Para [0004]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the treatment substance disclosed by Cattaneo, as modified, to comprise an anticoagulant as taught by Tsubouchi since Tsubouchi teaches that during extracorporeal circulation, blood is in an environment likely to be in contact with foreign bodies such as air, activated blood is likely to clot and form a thrombus so a thrombus is inhibited from being formed by giving a dose of an anticoagulant (Tsubouchi, Para [0004]).
Claims 3 and 17 is rejected under 35 U.S.C. 103 as being unpatentable over Cattaneo in view of Alesi and Goble as applied in claim 1 above, and further in view of Wang et al. (US 7473239 B2, herein, Wang).
Regarding claim 3, Cattaneo, as modified, discloses the catheter system set forth above, but Cattaneo does not expressly disclose wherein the major lumen is configured to be connected into an extra-corporeal membrane oxygenation support (ECMO) system.
Wang teaches, wherein a major lumen (52 – Fig.7) is configured to be connected into an extra-corporeal membrane oxygenation support (ECMO) system (84 – Fig.7)(Col.8, lines 22-27).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the catheter system disclosed by Cattaneo, as modified, so that the major lumen is connected to a ECMO system as taught by Wang to allow an efficient transfer of oxygen into relatively deoxygenated blood (Wang, Col.1, lines 63-65).
Regarding claim 17, Cattaneo, as modified, discloses the catheter system set forth above, but Cattaneo does not expressly disclose wherein the peripheral device is an ECMO system and further comprising venting blood from the left ventricle using the major lumen.
Wang teaches a method wherein they have a peripheral device that is an ECMO system (84 – Fig.7)(Col.8, lines 22-27).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the method of delivering a treatment substance disclosed by Cattaneo to use an ECMO system as taught by Wang since it allows an efficient transfer of oxygen into relatively deoxygenated blood (Wang, Col.1, lines 63-65).
Alesi teaches a method comprising venting blood from the left ventricle (“The blood is directed through inflow cannula and is subjected to the pumping energy of portable pump” – Para [0069]) using a major lumen (70 – Fig.20).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the method disclosed by Cattaneo, as modified, to vent blood from the left ventricle using a major lumen as taught by Alesi since it allows for partial bypass of the heart to supplement the pumping function of the heart to thereby enable the surgeon to perform various surgical procedures (Alesi, Para [0007]).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Cattaneo in view of Alesi and Goble as applied in claim 1 above, and further in view of Culley et al. (US Pub. No. 20120065579 A1, herein, Culley).
Regarding claim 7, Cattaneo, as modified, discloses the catheter system set forth above wherein the major lumen (2 – Fig.4) includes an outer surface (Fig.4) but Cattaneo do not expressly disclose wherein the outer surface of the major lumen comprises a thrombo-resistant coating.
Culley teaches wherein the outer surface of a major lumen comprises a thrombo-resistant coating (“Heparin may be attached to any surface of the central tube” – Para [0038]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the catheter system disclosed by Cattaneo, as modified, so that the lumen comprises a thrombo-resistant coating as taught by Culley since a coating of heparin can help prevent and/or reduce thrombosis formation on or in the tube (Culley, Para [0038]).
Regarding claim 8, Cattaneo, as modified, discloses the catheter system set forth above wherein the minor lumen (3 – Fig.4) includes an outer surface (Fig.4) but Cattaneo do not expressly disclose wherein the outer surface of the minor lumen comprises a thrombo-resistant coating.
Culley teaches wherein the outer surface of a minor lumen comprises a thrombo-resistant coating (“Heparin may be attached to any surface of the central tube” – Para [0038]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the catheter system disclosed by Cattaneo, as modified, so that the lumen comprises a thrombo-resistant coating as taught by Culley since a coating of heparin can help prevent and/or reduce thrombosis formation on or in the tube (Culley, Para [0038]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Cattaneo in view of Alesi, and Goble as applied in claim 1 above, and further in view of Trudel et al. (US Pub No. 20170215794 A1, herein, Trudel).
Regarding claim 20, Cattaneo, as modified, disclose the catheter system set forth above but Cattaneo does not expressly disclose wherein the catheter system comprises a handle coupled to the major lumen, and a flow meter coupled to the handle and in fluid communication with the major lumen and configured to measure volume of blood vented through the major lumen.
Trudel teaches a catheter system comprising a handle (106b – Fig.1B) coupled to the major lumen (103 – Fig.1A), and a flow meter (105 – Fig.1A) coupled to the handle (Fig.1A) and in fluid communication with the major lumen and configured to measure volume of blood vented through the major lumen (Para [0022]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the catheter system disclosed by Cattaneo, as modified, to comprise a handle and flow meter as taught by Trudel since the handle allows an operator to manipulate the distal portion of the catheter to ensure accurate placement and orientation within the patient’s body and to obtain one or more measurements related to one or more physiological parameters of the patient to ensure accurate and reliable monitoring of blood flow to avoid adverse effects (Trudel, Para [0022-0023]).
Conclusion
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/MARISSA TAYLOR/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783